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Evaluation of analgesic effect of surgical wound Infiltration of Open Cholecystectomy with Bupivacaine 0.25% with adrenaline in patients of santa casa de misericórdia de Sobral

Evaluation of analgesic effect of surgical wound Infiltration of Open Cholecystectomy with Bupivacaine 0.25% with adrenaline in patients of santa casa de misericórdia de Sobral

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-6wbpbq
Enrollment
Unknown
Registered
2015-12-23
Start date
2014-07-17
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cholecystectomy/ Bupivacaine infiltration

Interventions

All study patients will be submitted to the same anesthesia protocol. Anesthesia and neuromuscular blockade induction will be used fentanyl 3?g / kg
propofol 3mg / kg and atracurium 0.5mg / kg. Anesthetic maintenance by sevoflurane 3-4%. Analgesia: dipyrone 20mg / kg and 100 mg ketoprofen. As an antiemetic, it was used at a dose of 4 mg ondansetro
Drug
Procedure/surgery
E03.091

Sponsors

Santa Casa de Misericórdia de Sobral
Lead Sponsor
Universidade Federal do Ceará
Collaborator

Eligibility

Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: They should be included in previously healthy patients; ASA (American Society of Anesthesiologist) 1 or 2; between 18 and 70 years; of both sexes; undergoing elective open cholecystectomy surgery.

Exclusion criteria

Exclusion criteria: People will be excluded who do not agree to answer the questionnaire or refuse to validate the consent form; have any allergies to any of the drugs included in the program 's protocols.

Design outcomes

Primary

MeasureTime frame
Lower postoperative pain scores of patients undergoing bupivacaine infiltration 0.25% with vasoconstrictor medium, which should be observed by the Fisher method applied to those found the visual numeric scale of pain in the first four hours of the post operatively. Statistics of morphine sulfate consumption difference between the intervention and control groups, which will be observed by the Mann-Whitney test applied to the average amount consumed morphine sulfate recorded in a standardized monitoring plug between the two groups; Statistical difference in the incidence of nausea, vomiting and respiratory distress among patients in the intervention and control groups, which will be calculated using the chi square test applied to the proportions of incidence of such signs and symptoms (evidenced by clinical assessment).;The group infiltrated with bupivacaine in all periods observed had lower pain scores compared to the test group (control: 4.583 ± 0.554, 4.444 ± 0.506, 3.388 ± 0.405 vs Bupivacaine: 3.409 ± 0.371, 2.545 ± 0.313, 2.000 ± 0.329). By means of Fisher method, mean values and standard errors were found in hours 1, 2 and 4, and "p" with values of (0.046; 0.001; 0.019) respectively. The number of patients requested rescue analgesia was greater in the group infiltration with saline (50% vs. 18.18%). The consumption of morphine sulphate in the two groups had average in mg (2.63 ± 3.58 vs 1.15 ± 2.72; P = 0.136) (Mann-Whitney test), showing no significant difference. The incidence of nausea / vomiting infiltrated with bupivacaine group was lower than the control, but no changes were observed on the respiratory distress of the patients.

Secondary

MeasureTime frame
Secondary outcomes are not expected

Countries

Brazil

Contacts

Public ContactGerardo;Ítalo de Menezes Neto;Freire

Universidade Federal do Ceará;Universidade Federal do Ceará

gerardo.cristinomn@gmail.com;italo.nv@gmail.com+55 (88) 98801 5471;+55 (88) 99951 8570

Outcome results

None listed

Source: REBEC (via WHO ICTRP)